Last reviewed · How we verify
Afstyla®
Afstyla is a recombinant antithrombin III-free factor VIII that replaces deficient clotting factor VIII to restore hemostasis in patients with hemophilia A.
Afstyla is a recombinant antithrombin III-free factor VIII that replaces deficient clotting factor VIII to restore hemostasis in patients with hemophilia A. Used for Hemophilia A (congenital factor VIII deficiency) for routine prophylaxis and treatment of bleeding episodes.
At a glance
| Generic name | Afstyla® |
|---|---|
| Also known as | CSL627 |
| Sponsor | CSL Behring |
| Drug class | Recombinant clotting factor VIII |
| Target | Factor VIII (coagulation factor VIII) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Afstyla is a B-domain deleted recombinant factor VIII (rFVIII-SingleChain) produced using a single-chain construct that improves stability and half-life compared to conventional recombinant factor VIII products. It functions as a cofactor in the intrinsic coagulation pathway, enabling the formation of the tenase complex with factor IX to activate factor X, thereby restoring the ability to generate thrombin and form stable blood clots in hemophilia A patients.
Approved indications
- Hemophilia A (congenital factor VIII deficiency) for routine prophylaxis and treatment of bleeding episodes
Common side effects
- Inhibitor development (factor VIII antibodies)
- Injection site reactions
- Headache
- Hypersensitivity reactions
Key clinical trials
- SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis (PHASE3)
- Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A (PHASE1)
- An Observational Study Called JOIHA to Learn More About How Well the Treatment With Jivi Works to Prevent Problems With Joints in Adults With Hemophilia A.
- Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study) (PHASE4)
- Register of Patients With haEmophilia A tReated With Afstyla®
- A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD (PHASE3)
- Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor (PHASE4)
- rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Afstyla® CI brief — competitive landscape report
- Afstyla® updates RSS · CI watch RSS
- CSL Behring portfolio CI